D-1387-2020 Class II Terminated
FDA drug recall D-1387-2020 was initiated by RemedyRepack Inc. on June 29, 2020 and is designated Class II. Reason for recall: FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing. The recall status is terminated (terminated September 14, 2020). Affected quantity: 498 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2020
- Initiation Date
- June 29, 2020
- Termination Date
- September 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 498 tablets
Product Description
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
Reason for Recall
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Distribution Pattern
Product was distributed to MN.
Code Information
Lot #: B0796217-020920, Exp. Date: 02/28/2021